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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP

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SOFRADIM PRODUCTION SAS PROGRIP Back to Search Results
Model Number TMP1515G
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cellulitis (1768); Unspecified Infection (1930); Urinary Tract Infection (2120); Post Operative Wound Infection (2446)
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the survey response about procedures where a self-fixating mesh was used, the following complications were encountered: 2 patients experience recurrence, one specific to retromuscular occurrence. 1 patient experienced mesh infection. 20 patients experienced seroma/hematoma, which can occur with prosthesis. 4 patients experienced infection (wound infection, abdominal wall cellulitis, urinary tract infection), that was superficial or banal. 5 patients experienced usual post-operative complications (prolonged ileus, urinary retention, wound complications) which are common with hernia procedures.

 
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Brand NamePROGRIP
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key8950330
MDR Text Key156131657
Report Number9615742-2019-02940
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 08/30/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/30/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTMP1515G
Device Catalogue NumberTMP1515G
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/07/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/30/2019 Patient Sequence Number: 1
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